Process Validation has the scope to provide a documented act which demonstrate that the process is consistent, replicable, and produce the expected result or comply with expected product specifications, in other words supply the evidence of the Product Quality.
The FDA and EMA, guideline describe the new Validation approach.
“Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”
(FDA, Guidance for Industry – Process Validation: General Principles and Practices, January 2011)
“Continuous Process Verification (CPV) is an alternative approach to traditional process validation in which
manufacturing process performance is continuously monitored and evaluated (ICH Q8).”
(EMA, Guideline on Process Validation – Draft, 2012)
PTM Consulting using a Risk-based Validation & Continuous Process Verification approach, allows to reduce times and efforts of the validation activities, helping to increase productivity and the profitability.
The PTM Methodology inspired to Guide lines ICH Q9 and of the Annex 15 to the GMP “Qualification and Validation” allows:
- Improvement of Product and Process Knowledge, building a consistent control strategy;
- Take Informed Decisions, thanks to the use of technical analysis tools, supporting planning of Validation Activities